Clinical trials: Vascular Closure Devices
Femoral Arteriotomy Closure
X-Seal EU Post-Market Clinical Follow-Up Protocol
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone…
- Trial name
- NCT02406612
- Testing
- X-Seal 6F Vascular Closure Device
- Where
- 2 sites in Germany
- Volunteers
- 47 people
- Sponsor
- Essential Medical, Inc.
Venous Vascular Closure
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs.
- Trial name
- ReliaSeal (NCT05554471)
- Testing
- MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
- Where
- 14 sites in United States
- Volunteers
- 352 people
- Sponsor
- Cordis US Corp.
Femoral Arteriotomy Closure
MANTA Ultrasound Closure Study
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
- Trial name
- MANTA ULTRA (NCT05142566)
- Testing
- MANTA Vascular Closure Device
- Where
- 6 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Essential Medical, Inc.
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates
Cardiac Disease, Coronary Artery Disease
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who…
- Trial name
- NCT01600482
- Testing
- CELT ACD
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 241 people
- Sponsor
- Vasorum Ltd
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Coronary Artery Disease
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention…
- Trial name
- ARISTOCRAT (NCT02061696)
- Testing
- Vascular Access Device, Standard Manual Compression
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Frank Saltiel
Femoral Arteriotomy Closure
MANTA Registry for Vascular Large-bore Closure
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for…
- Trial name
- MARVEL (NCT03330002)
- Testing
- CE-marked MANTA vascular closure device (VCD)
- Where
- 9 sites in Canada, Denmark and 3 more
- Volunteers
- 500 people
- Sponsor
- Essential Medical, Inc.
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix
Cardioembolic Stroke, Atrial Fibrillation
Left Atrial Appendage Closure With SentreHeart Lariat® Device
The study cohort will consist of up to 50 patients who are candidates for Left Atrial Appendage (LAA) closure in whom oral anticoagulation is contraindicated.
- Trial name
- Lariat (NCT02681042)
- Testing
- Left atrial appendage closure, SentreHeart Lariat®
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Baylor Research Institute
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Bleeding
HEAL-LAA Clinical Trial
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Bleeding, Stroke
- Trial name
- HEAL-LAA (NCT05809596)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 45 sites in United States
- Volunteers
- 949 people
- Sponsor
- Boston Scientific Corporation
Catheterization Via a Femoral Sheath ≤ 6Fr
CaveoVasc System - a New Femoral Vascular Access and Closure Device
The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
- Trial name
- NCT02694549
- Testing
- CaveoVasc
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CaveoMed GmbH
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Acute Coronary Syndrome
AngioSeal Versus Radial Approach in Acute Coronary Syndrome
Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence…
- Trial name
- ARISE (NCT01653587)
- Testing
- Percutaneous coronary intervention
- Where
- Brazil
- Volunteers
- 240 people
- Sponsor
- Irmandade Santa Casa Misericórdia Marília
Vascular Closure
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
- Trial name
- SEAL PM (NCT01858636)
- Testing
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
- Where
- 6 sites in Germany, Netherlands
- Volunteers
- 235 people
- Sponsor
- Abbott Medical Devices
Endovascular
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular…
- Trial name
- PANDA (NCT03923387)
- Testing
- MynxGrip, Manual compression
- Where
- China
- Volunteers
- 306 people
- Sponsor
- Cordis US Corp.
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral…
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis, Peripheral Arteriosclerosis
- Trial name
- NCT00345631
- Testing
- Manual Compression, Vascular Closure Device
- Where
- 17 sites in United States
- Volunteers
- 488 people
- Sponsor
- Cordis US Corp.
Arterial Occlusion, Cardiovascular Diseases
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Hematoma
- Trial name
- NCT05637970
- Testing
- Perclose, Statseal
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, Los Angeles